Prescription medicine
Daptomycin Brand names: Dapzura; first approved as Cubicin
Daptomycin (Cubicin) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $23.80 per daptomycin 500 mg vial in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the daptomycin FDA label on DailyMed (effective May 8, 2026, Hospira, Inc.); the NDA 21572 record on Drugs@FDA; every daptomycin label on DailyMed.
Highlights of the record
FDA label of May 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDaptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (cSSSI) in adult patients ( 1.1 ) and,
Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) Limitations of Use:
This Daptomycin for Injection product is not approved for use in pediatric pat
Forms and strengths
- 500 mg
- 50 mg/ml
- 350 mg/7ml
- 350 mg/50ml
- 500 mg/10ml
- 500 mg/20ml
- 500 mg/50ml
- 700 mg/100ml
- 1000 mg/100ml
Injection (powder) (lyophilized) for solution; injection (solution); injection (powder) (lyophilized) for suspension.
On the market
- Earliest approval on file
- September 12, 2003 Cubicin, Cubist Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first September 12, 2014; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 23 under generic applications, 8 under brand applications, repackagers included
- Last listed patent
- November 23, 2030 Cubicin injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $23.80 per vial Daptomycin 500 mg vial
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 6 since 2016 2 Class I among all firms' recalls; latest August 6, 2026; 5 more by firms not listed as its makers
- FAERS reports
- 9,171 through July 30, 2026
What is daptomycin used for?
From the label: indications and usageDaptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (cSSSI) in adult patients ( 1.1 ) and,
Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) Limitations of Use:
This Daptomycin for Injection product is not approved for use in pediatric patients. ( 1.3 )
Daptomycin for Injection is not indicated for the treatment of pneumonia. ( 1.3 )
Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. […]
FDA pharmacologic class: Lipopeptide Antibacterial.
Source: FDA drug label (Daptomycin), Hospira, Inc., effective May 8, 2026 (SPL set 1957b6ce-7382-4a7b-bf02-3595948d09c6), via openFDA; the full label on DailyMed
Is there a generic for daptomycin (Cubicin)?
The FDA approved the first generic daptomycin on September 12, 2014. 25 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists daptomycin from 23 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Cubicin injection, the last expiring on November 23, 2030; a patent listed only for Daptomycin injection runs to January 9, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2003 earliest approval on file
- 2014 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for daptomycin (Cubicin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $23.80 per Daptomycin 500 mg vial, down 2% from $24.27 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Daptomycin 500 mg vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Daptomycin 500 mg vial | Generic | $23.80 per vial | n/a | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is daptomycin in shortage?
No daptomycin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated June 30, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Daptomycin, Injection, 500 mg/10 mL (NDC 0143-9378-01) | Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | To Be Discontinued | June 30, 2026 |
| Daptomycin, Injection, 500 mg/10 mL (NDC 57884-3151-1) | Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | To Be Discontinued | June 30, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has daptomycin been recalled?
The FDA's Enforcement Report lists 11 recalls naming daptomycin since 2016: 2 Class I (the most serious), 9 Class II, 0 Class III; 2 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of daptomycin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 6, 2026 | Class II | Baxter Healthcare Corporation | CGMP Deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| November 29, 2022 | Class I | Accord Healthcare, Inc. | Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial |
| July 7, 2020 | Class I | Mylan Institutional LLC | Presence of Particulate Matter |
| February 24, 2020 | Class II | Redline Pharmacy Solutions not a listed maker | Lack Of Processing Controls |
| June 28, 2018 | Class II | PFIZER not a listed maker | Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological … |
| April 18, 2016 | Class II | Baptist Health Medical Towers Pharmacy and Infusion Services not a listed maker | Lack of Sterility Assurance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the daptomycin label say about other medicines?
The daptomycin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name daptomycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Simvastatin | drug interactions | DRUG INTERACTIONS 7.1 HMG-CoA Reductase Inhibitors In healthy adult subjects, concomitant administration of daptomycin and simvastatin had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy [see Clinical Pharmacology (12.3) ]. |
Source: FDA drug label (Daptomycin), Hospira, Inc., effective May 8, 2026 (SPL set 1957b6ce-7382-4a7b-bf02-3595948d09c6), via openFDA; the full label on DailyMed
What do FAERS reports show for daptomycin?
The FDA Adverse Event Reporting System holds 9,171 reports that list daptomycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,268 are coded as a death and 5,223 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Daptomycin side effects
- the label's list beside FAERS reports
- Daptomycin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other